鲎试剂

目的：对刺五加注射液进行细菌内毒素检查。方法：鲎试剂法。

OBJECTIVE : To observe the bacterial endotoxins test of Radix acanthopanacis senticosi injection METHODS : TAL method was test .

结果样品经稀释后可消除对鲎试剂的干扰作用，3批样品中细菌内毒素的量均低于50EU/ml。

RESULTS : The interference of the dilute ~ ( 131 )ⅰ - epidepride injection on TAL can be eliminated after dilution , the bacterial endotoxin levels for 3 batches of 131 ⅰ - epidepride injection were all below 50EU / ml.

鲎试剂法定量检测PVC一次性输液（血）器材中内毒素浓度

Quantitative Determination of Endotoxin Concentration in PVC Disposable Transfusion Set by Limulus Test

结果：纯化的LPS用紫外/可见光分光光度计扫描，呈单一吸收峰，并能被鲎试剂特异检出。

Results : Single peak of LPS is obtained using Violet spectrophotometer and LPS can be detected by limulus reagents .

采用鲎试剂法测血浆LPS浓度；鲎试剂在抗淋巴细胞免疫球蛋白热原检测中的应用

The LPS concentration of plasma was detected by limulus lysate test . Application of Limulus Amoebocyte Lysate Reagent to Estimating Pyrogen in Antilymphocyte Immunoglobulin

方法：采用鲎试剂基质显色法定量测定内毒素，用放射免疫法测定ET，常规生化法测定血肌酐，同时留24小时尿液测定尿肌酐与尿钠。

METHODS : The plasma endotoxin , endothelin , creatinine , and 24 hours urine creatinine and sodium were measured by Limulus test method , radioimmunological method and biochemical analysis , respectively .

mL-1的溶液后，可用灵敏度为0.25EU.mL-1的鲎试剂进行检测。

The limulus amebocyte lysate reagent with the sensitivity of 0.25 EU · mL-1 could be used in the test .

结果：盐酸洛美沙星葡萄糖注射液对鲎试剂的凝集反应有干扰作用，调节药液pH值至68～72可消除干扰，用灵敏度为025EU/ml的鲎试剂可进行细菌内毒素检查。

RESULTS : Lomefloxacin and glucose injection could interfere with limulus test , however , the interference could be eliminated after adjusting the pH of injection to 6.8 ~ 7.0.The proper concentration of limulus test agent of bacterial endotoxin test was 0.25EU/ml .

结果：SAGM红细胞保存液经2倍稀释后对鲎试剂反应无干扰作用。

RESULTS : There was no interference action of twofold diluted SAGM fluid on limulus test .

采用鲎试剂凝胶法检测人参提取物和人参皂甙Rb1中的内毒素含量。结果表明人参提取物和人参皂甙Rb1对凝胶法检测内毒素无干扰作用，内毒素含最小于0.5EU／ml。

The results indicated that ginseng extract and ginsenoside Rbl did not interfere with amebocyte lysate assay and the concentration of endotoxin was less than 0.5EU/ml in the ginsenosides .

方法：将3批样品用两个不同厂家生产的鲎试剂，按《中国药典》2000年版二部附录E方法进行干扰试验考察。

Method : The interference test of 3 batches of Buflomedil Hydrochloride Sodium Chloride Injection with 2 kinds of limulus test agent was done according to the method in appendix of China Pharmacopoeia ( Volume ⅱ Appendix ⅺ E , 2000 edition ) .

结果表明用鲎试剂灵敏度（λ）0.5EU／ml相对应的有效浓度进行试验，有蛋氨酸等11种氨基酸无干扰作用。

P. ( Chinese Pharmacopeia ) 1995 , and other reference , Using concentration of sample solution vs to the sensitivity of LAL reagent is 0 . 5EU / ml , results shows that eleven individual amino acids have no interference .

方法：按《中国药典》（二部）2000年版规定，用不同厂家生产的鲎试剂（TAL）对SAGM红细胞保存液进行细菌内毒素检查法干扰试验。

METHODS : Interference test was carried on endotoxin detection of SAGM erythrocyte preserve fluid with test agent of limulus ( TAL ) .

结果：样品采用灵敏度0.125EU·ml-1的鲎试剂经干扰实验无增强抑制作用。

Result ; Using limulus amebocyte lysate ( LAL ) with the sensitivity of 0 . 125 EU · ML-1 for interfere factors test , there was no inhibition or enhancement action .

采用灵敏度为0.5EU/ml的鲎试剂可进行细菌内毒素检查。【结论】细菌内毒素法适用于注射用奥扎格雷钠的热原检查。

【 Conclusion 】 The method of bacterial endotoxin is suitable for the pyrogen determination of ozagrel sodium .

强电离放电等离子体洗消沙林模拟剂DMMP试验方法采用2个厂家的鲎试剂对盐酸克林霉素注射液进行干扰试验。

Experiments of sarin simulant DMMP decontamination by strong ionization discharging plasma METHODS The interfering action of Clindamycin Hydrochloride Injection and limulus lysate agent from two manufacturers were investigated .

结论：在1：12的稀释度下，可用灵敏度为0.25EU·mL的鲎试剂进行细菌内毒素检查，从而控制细菌内毒素的限量。

Conclusion : The bacterial endotoxin test can be carried out with 0.25 EU · mL sensitivity of TAL when the dilutability of sample 1:12 , the limit dose of bacterial endotoxin is controlled thereby .

结论：替硝唑葡萄糖注射液稀释到0.5mg·ml~（1）即可消除其对鲎试剂的干扰，可用于常规检验。

Conclusion : The TGI diluted into 0.5 mg · ml-1 may eliminate its obstruction to TAL reagent , and may be used in routine test .

结果葛根素注射液稀释到2.083g·L-1浓度1→24后可消除对鲎试剂的干扰，用灵敏度为0.25EU·ml-1的鲎试剂检测内毒素是有效的，并与家兔法的结果一致。

It was effective that endotoxins were tested by amebocyte lysate agent with the sensitivity of 0.25 EU · ml ~ - 1 , and was consistent with rabbit method .

方法：鲎试剂检测原料、半成品、成品，灵敏度0.25EU·ml~（-1）。

METHOD : Tachypleus reagent was used to examine raw material , half product and product . The sensitivity is 0.25 EU per centimeter .

目的研究鲎试剂法与家兔法检测重组人干扰素α2b内毒素结果的相关性，并参照家兔热原试验的阈值量，来确定本制品质量标准中内毒素的限量标准。

Objective To study the relationship between the determination results of bacterial endotoxin by limulus test and rabbit test , and to determine the limit of bacterial endotoxin content in the product according to the threshold value defined in pyrogen test in rabbits .

结果：对于小牛血去蛋白提取物注射液（原液），可用标示灵敏度为0.5EU/mL的鲎试剂进行细菌内毒素检查。

Results : Deproteinized calf blood extractive injection was assayed by tachypleus amebocyte lysate labeled the sensitivity of 0.5 EU / mL for endotoxin .

结果眼镜蛇毒与0.5EU/ml鲎试剂产生凝集反应的浓度在5.0μg/ml以上；

Results The concentration for cobratoxin to produce agglutination reaction is above 5.0 μ g / ml in action with 0.5EU/ml 1 limulus reagent .

结论对甘油氯化钠注射液进行2倍稀释以0.5EU/ml的鲎试剂检查其热原是可行的。

[ WTHZ ] Conclusion Compound glycerin injection in 2-fold dilution applied in 0.5 EU / ml limulus reagent in detection of its pyrogen is feasible .

结果发现三批鲎试剂的灵敏度标示值均正确，五批抗淋巴细胞免疫球蛋白半成品在最大有效稀释度（MVD）时对试验无干扰，这两种方法测定结果的符合率达到91.7%。

The result showed that the labeled values of three LAL reagent sensitivity were right and there was no interference to the test in five ALG diluted to Maximum Valid Dilution ( MVD ) . The coincidence rate of two tests was 91.7 % . all effective .

结果：复方利多卡因注射液对鲎试剂的凝集反应无干扰作用，用灵敏度0.5EU/ml的鲎试剂检查细菌内毒素的方法可行有效。

Results : The test using limulus agent with a sensitivity of 0.5 Eu / m showed that the reaction was not interfered by compound lidocaine injection .

结果：将新鱼腥草素钠注射液稀释30倍，用标示灵敏度为0.5EU·ml-1的鲎试剂进行细菌内毒素检查是有效的。

Result : The experiment showed that the interference elements could be excluded by diluting sodium new houttuyfonate injection to 30 times , and it was effective that the bacterial endotoxins could be tested by amebocyte lysate with accuracy of 0.5 EU / ml.

方法：参考《中国药典》2000年版附录细菌内毒素检查法。结果：FuDR注射液60倍稀释液可用灵敏度05EU/ml鲎试剂做细菌内毒素检查。

METHODS : To refer to BET in appendix of China Pharmacopoeia , edition 2000 . RESULTS : Bacterial endotoxin could be detected in 60 times dilution of FuDR injection by limulus lysate with a sensitivity of 0.5EU/ml .

结果确定生脉注射液细菌内毒素限值为3.75EU/mL，最佳检测条件为供试品稀释10倍，特异性鲎试剂灵敏度为0.25EU/mL。

RESULTS The bacterial endotoxins limit value of Shengmai injection was 3.75EU/mL and the experiment showed that the interference elements could be excluded by diluting Shengmai injection 10 times .

目的：探讨用中国的细菌内毒素工作标准品（CSE）和鲎试剂（TAL）替代美国的细菌内毒素参考标准品（RSE）和鲎试剂（LAL）来检测硫酸链霉素的细菌内毒素的可行性。

Objective : To discuss the feasibility of using Chinese control standard endotoxin ( CSE ) and Tachypleus Amoebocyte Lysate ( TAL ) to substitute the USP Reference Standard Endotoxin ( RSE ) and Limulus Amebocyte Lysate ( LAL ) on the bacterial endotoxins test for streptomycin sulfate .